3/24/2022

speaker
Conference Operator
Operator

Good afternoon, ladies and gentlemen, and welcome to the IntelliGenX fourth quarter and full year 2021 financial results conference call. At this time, all participants have been placed in a listen-only mode. We will open the floor for your questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, Steve Kilmer. Sir, the floor is yours.

speaker
Steve Kilmer
Host

Thank you. Good afternoon, everyone, and thank you for joining us on today's call. With me on the line are Dr. Horst Zerbe, IntelliGenX's CEO, Andre Godin, our President and CFO, Tommy Kenney, our General Counsel, and Dr. Dana Madsen, the company's Vice President of Business and Corporate Development. Before we begin, I would like to remind you that all amounts mentioned today are in U.S. dollars, unless otherwise mentioned, and today's call may contain forward-looking information that represents our expectations as of today and accordingly are subject to change. We do not undertake any obligation to update any forward-looking statements, except as may be required by U.S. and Canadian securities laws. A number of assumptions were made by us in preparing these forward-looking statements, which are subject to risks and results may differ materially. Details on the risks and assumptions can be found in our filings with the U.S. and Canadian Securities Commissions. I would like now to turn the call over to Dr. Zerbe. Horst?

speaker
Dr. Horst Zerbe
Chief Executive Officer

Thank you, Steve. Good afternoon, everyone. This is the fourth quarter and full year 2021 conference call. On today's call, I will provide a corporate update and discuss the progress we have made on our key pipeline projects. Then, André will review our Q4 and full year 2021 financial results. Following that, we will open up the line for your questions. First on our Atai partnership, in March of last year, we announced our strategic partnership with Atai Life Sciences, which has positioned us as a leading developer and manufacturer in the psychedelic therapeutic space, while also providing the financial capacity to continue progressing our pharmaceutical film product candidates towards commercialization. In connection with this partnership, Atai acquired approximately 25% of Intergenics for approximately $12.3 million. and granted us an initial secured loan in the amount of $2 million. Atai subsequently granted us a second secured loan in the amount of $500,000. In May, we entered into a second feasibility agreement with Atai for the development of novel formulations of salvinorin A, a naturally occurring psychedelic compound based on Intergenic's polymeric film technologies. In September, we entered into an amended and restated secured loan agreement with Attai, which committed $6 million in future financial support to Intergenix. This loan was required for us to meet certain requirements in conjunction with our uplisting to the TSX Big Board. Our stock began trading on Canada's most senior exchange on October the 7th. Our graduation to the TSX marks an important milestone for intergenics and should support the development of a stronger profile in the investment community. Last month, we received a third term loan from Atai in the amount of $3 million. We look forward to continuing to work with Atai to develop more efficacious treatments for patients with treatment-resistant depression and other mental health indications. Moving on to ResaPort, in September, we were pleased to announce that Exceltis, our ResaPort commercialization partner in 27 European Union countries, launched ResaPort in Spain. This was the first Versafilm-based product to launch in the global pharmaceutical market and was a major milestone for Intergenics. With the European migraine drug market expected to approach $1.5 billion by 2024, we are looking forward to working with Exceltis to launch Resupport in additional European countries in the future. Two words on Tadalafil. In September, we announced that Equestria Therapeutics, our co-development and commercialization partner for Tadalafil oral films, entered into a definitive license and supply agreement with an undisclosed leading men's health company. This is an important development in our collaboration with Equestiv that will help make Tadalafil oral films available to men suffering from erectile dysfunction and benign prostatic hyperplasia, or BPH. On cannabis films, in February of last year, the United States Patent and Trademark Office granted a notice of allowance for our U.S. patent application covering novel disintegrating oral film formulations designed for the transmucosal absorption of drug, especially tetrahydrocannabinol, or THC. This patent is intended to protect or disinfect products which enable THC absorption via the oral cavity thus minimizing the amount of THC that becomes subjected to unwanted oral first pass metabolism. In August, we transitioned from a development to commercial stage company by completing our initial shipment of CBD film strips in support of heritage cannabis launch of the CB4 control brand in Canada. We're looking forward to continuing to work with Heritage on all thin-film cannabis products. On Montelukast, in January, we were finally able to resume patient enrollment and dosing in our Phase II Buena clinical trial in patients with mild to moderate Alzheimer's disease. This proof of concept study is proceeding under the amended protocol with a higher daily dose that was previously cleared by Health Canada. We're looking forward to collecting valuable data on Monteluca's Versafilm safety, feasibility, tolerability, and efficacy for the treatment of mild to moderate Alzheimer's disease. In addition, we expect to explore the product's candidate's efficacy in a couple of other major indications. We hope to announce those details soon. Now a few words on animal health. In February of last year, Intergenics filed a new provisional patent application at the USPTO that covers the incorporation of high concentrations of active ingredients in products based on our beta-film proprietary veterinary oral film technology. This higher loading capability enables a formulation with the ratio of active to polymer of one to one So this new patent will allow us to incorporate high amounts of drug into our film while still keeping it small enough to administer easily to companion animals. Back in early 2020, we entered into a feasibility study agreement with an undisclosed partner for an undisclosed molecule for buccal absorption using intergenic proprietary Betafilm platforms. This feasibility study was successful, and in October of 2021, we entered into an additional R&D agreement with this undisclosed company to further optimize the buccal film and to manufacture films for a clinical study. And with that, I would now like to turn the call over to André for review of our financial results. André?

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